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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00634933 |
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Date of registration:
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05/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
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Scientific title:
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A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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222 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00634933 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Belgium
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Canada
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France
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Germany
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Hungary
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Mexico
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Netherlands
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Romania
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Serbia
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of
methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of
anti-TNF use.
Exclusion Criteria:
- Any prior use of rituximab or other B cell depleting agents.
- Any significant health problem other than rheumatoid arthritis
- Clinically significant laboratory abnormalities
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Drug: Methylprednisolone
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Drug: TRU-015
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Drug: Prednisone
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Primary Outcome(s)
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Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
[Time Frame: Week 24]
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Secondary Outcome(s)
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36-Item Short-Form Health Survey (SF-36)
[Time Frame: Baseline, Week 12, 24, 36, 52]
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Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
[Time Frame: Baseline, Week 12, 24, 36, 52]
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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
[Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Physician Global Assessment (PGA) of Disease Activity
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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General Health Visual Analog Scale (VAS)
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
[Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Disease Activity Score Based on 28-joints Count (DAS28)
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
[Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Visual Analogue Scale for Pain (VAS-pain)
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score
[Time Frame: Baseline, Week 12, 24, 36, 52]
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Duration of Morning Stiffness
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Patient Global Assessment (PtGA) of Disease Activity
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
[Time Frame: Baseline, Week 12, 24, 36, 52]
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Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
[Time Frame: Baseline, Week 12, 24, 36, 52]
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Number of Tender Joints
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
[Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52]
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Health Assessment Questionnaire Disability Index (HAQ-DI)
[Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Number of Swollen Joints
[Time Frame: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
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Secondary ID(s)
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3206K1-2203
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B2051001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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